UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report (Date of earliest event reported):
March 13, 2006
(Exact name of registrant as specified in its charter)
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Delaware
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0-17085
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95-3698422
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(State
of other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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14272
Franklin Avenue, Tustin, California 92780
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(Address
of Principal Executive Offices)
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Registrant’s
telephone number, including area code: (714)
508-6000
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Not
Applicable
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(Former
name or former address, if changed since last
report)
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Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
o
Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
On
March
13, 2006, Peregrine Pharmaceuticals, Inc. issued a press release to report
the
Company’s financial results for the quarter ended January 31, 2006. A copy of
the press release is attached to this current report on Form 8-K as Exhibit
99.1. No additional information is included in this Current Report on Form
8-K.
The
information included in this Current Report on Form 8-K, including the exhibit
hereto, shall not be deemed “filed” for purposes of, nor shall it be deemed
incorporated by reference in, any filing under the Securities Act of 1933 or
the
Securities Exchange Act of 1934, except as expressly set forth by specific
reference in such a filing.
(c)
Exhibits. The following material is filed as an exhibit to this Current
Report on Form 8-K:
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Exhibit
Number
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99.1
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Press
Release issued March 13, 2006
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Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| PEREGRINE PHARMACEUTICALS, INC. | ||
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| Date: March 13, 2006 | By: | /s/ STEVEN W. KING |
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Steven
W. King,
President
and
Chief Executive Officer
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EXHIBIT
INDEX
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Exhibit
Number
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Description
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99.1
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Press
Release issued March 13, 2006
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Exhibit
99.1
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Investors
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Media
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|||
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Brod
& Schaffer
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Barbara
Lindheim
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(800)
987-8256
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GendeLLindheim
BioCom Partners
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ir@peregrineinc.com
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(212)
918-4650
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PEREGRINE
PHARMACEUTICALS REPORTS FISCAL YEAR 2006
THIRD
QUARTER RESULTS
TUSTIN,
Calif., March 13, 2006
--
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM),
a
biopharmaceutical company with a portfolio of innovative, clinical stage
products for the treatment of viral diseases and cancer, today announced
financial results for the third quarter of fiscal year 2006 ended January 31,
2006. The company reported a consolidated net loss of $3,113,000, or $0.02
per
basic and diluted share, compared to $3,744,000, or $0.03 per basic and diluted
share, for the same prior year period.
Total
revenues for the current quarter were $1,528,000, of which $1,505,000 were
attributable to Avid Bioservices, the company’s wholly owned contract
manufacturing subsidiary. This compares to total revenues of $1,353,000 for
the
comparable quarter last year. Results for the period benefited from increased
revenues at Avid as it ramped up for the unit’s new commercial production
contract with Halozyme Therapeutics.
“Since
we
last reported, we have continued our progress in our key programs,” said Steven
W. King, president and CEO of Peregrine. “We completed planned patient
enrollment in the Tarvacin™ Anti-Viral
Phase I
trial in Hepatitis C infected patients and presented positive top-line safety
data in February, well ahead of our previous target of mid-2006. Presentation
of
this first human data was a major milestone for Tarvacin, our first-in-class
targeted product candidate with a wholly new mechanism for addressing viral
diseases and cancer. Moving forward, we are pursuing several strategies to
accelerate our Tarvacin Anti-Viral
and
Tarvacin Anti-Cancer
programs, as well as our Cotara® program in brain cancer. We are increasing our
preclinical and clinical program collaborations with top researchers and
institutions in target therapeutic areas and are also moving forward with plans
to facilitate patient enrollment by initiating clinical trials outside the
U.S.,
focusing initially on cancer studies for Tarvacin Anti-Cancer
and
Cotara.“
Total
costs and expenses increased $851,000 to $6,010,000 for the 2006 third quarter
from $5,159,000 for the same quarter last year. This increase was primarily
due
to higher research and development expenses associated with the advancement
of
the company’s clinical and preclinical product candidates combined with an
increase in selling, general and administrative expenses. This was partially
offset by a decrease in cost of sales associated with Avid Bioservices.
---more---
Interest
and other income increased $1,316,000 during the current quarter over the prior
year quarter primarily due to the recovery of a fully reserved for note
receivable in the amount of $1,229,000 that was paid off in December
2005.
At
January 31, 2006, the company had $15,664,000 in cash and cash equivalents,
compared to $9,816,000 at fiscal year end April 30, 2005.
Update
on Tarvacin™ Programs
Tarvacin
Anti-Viral
Planned
enrollment and dosing in the Tarvacin Anti-Viral
Phase I
Hepatitis C virus (HCV) trial was completed in mid-February. Positive top-line
safety data from the study was presented at the "Viral Hepatitis in Drug
Discovery and Development" conference in Boston on February 27th.
Data
from this trial should enable Peregrine to move rapidly into repeat dose studies
in HCV, which the company expects to begin by mid-2006 and anticipates
completing patient enrollment by calendar
year-end.
The
company also expects to initiate and complete patient enrollment in an HCV
combination therapy study by calendar year-end and is currently on track to
achieve these goals. The Tarvacin Anti-Viral
program
is also expected to benefit from the recent addition of Dr. John G. McHutchison,
a highly regarded global HCV expert, to the company’s Scientific Resource
Board.
Peregrine
is also continuing to evaluate the potential of Tarvacin in preclinical models
for the treatment of other serious viral infections including seasonal and
pandemic influenza, cytomegalovirus and HIV. The company plans to initiate
trials in one to two additional anti-viral indications during 2006 pending
positive results from these preclinical studies.
To
advance further its preclinical and clinical anti-viral programs, Peregrine
is
continuing to expand its collaborations with private contract laboratories,
major universities and federal government agencies, including the National
Institute of Allergy and Infectious Diseases and the U.S. Department of Defense
(DOD).
Tarvacin
Anti-Cancer
The
Phase
I trial of Tarvacin Anti-Cancer
is now
ongoing at five clinical sites. Peregrine is on track to complete patient
enrollment in this trial by the end of calendar year 2006. The company is
evaluating options to accelerate the program including expanding its Tarvacin
Anti-Cancer
studies
to additional sites. Possibilities include initiating clinical research programs
outside the U.S.
Early
evidence of Tarvacin’s potential to treat a number of major solid tumor cancers
was further boosted during the quarter when Peregrine’s research collaborators
at the University
---more---
of
Texas
Southwestern Medical Center at Dallas published a study in the
International Journal of Oncology
reporting that a mouse equivalent of the Tarvacin antibody in combination with
standard chemotherapy demonstrated encouraging efficacy in both shrinking
primary tumors and reducing metastatic disease in well-validated preclinical
pancreatic cancer models. In January 2006, the Defense Department awarded a
second grant to UT Southwestern to conduct preclinical studies of Tarvacin
Anti-Cancer as a potential treatment for prostate cancer. Results from these
studies are expected to help accelerate the start of additional clinical trials
once the current Phase l cancer trial is successfully completed. With this
new
project, the total DOD commitment to Tarvacin prostate cancer research exceeds
one million dollars. Altogether more than three million dollars in aggregate
grant funding has been awarded to UT Southwestern researchers to study Tarvacin
in anti-cancer and anti-viral applications demonstrating a growing support
for
this first-in-class targeted therapeutic.
Update
on Cotara® Program
Peregrine
is continuing its Cotara development program in patients with recurrent brain
cancer through its collaboration with the New Approaches to Brain Tumor Therapy
(NABTT) Consortium. The company expects to complete enrollment in the NABTT
study by calendar year-end. In addition, Peregrine is actively evaluating plans
to initiate a Cotara clinical study outside the U.S. to expedite clinical
development.
Conference
Call:
The
company will host a conference call on Monday, March 13, 2006 at 11:00 a.m.
ET/
8:00 a.m. PT to discuss its third quarter results.
To
listen
to a live broadcast of the call over the Internet, please visit: www.peregrineinc.com.
The
broadcast will be archived on Peregrine’s website for approximately 30 days.
To
listen
to the live teleconference by telephone, please dial 1-800-860-2442. A
telephonic replay of the conference call will also be available through March
20, 2006, by calling 1-877-344-7529 and entering passcode 382933#.
About
Peregrine Pharmaceuticals
Peregrine
Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of
innovative product candidates in clinical trials for the treatment of cancer
and
viral diseases. The company is pursuing three separate clinical trials in cancer
and anti-viral indications with its lead product candidates Tarvacin™ and
Cotara®. Peregrine also has in-house manufacturing capabilities through its
wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com),
which
provides development and biomanufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be found at
www.peregrineinc.com.
Safe
Harbor Statement: Statements in this press release which are not purely
historical including statements regarding Peregrine Pharmaceuticals’ intentions,
hopes, beliefs, expectations, representations, projections, plans or predictions
of the future are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The forward-looking statements involve
risks and uncertainties, including, but not
---more---
limited
to, the following: that safety and efficacy studies in the Phase I clinical
cancer study may
not correlate to safety and efficacy data from the preclinical animal models,
the timing of enrolling all patients in any clinical trial, that preclinical
binding studies of Tarvacin™ against various enveloped viruses may prove to be
ineffective during clinical testing, the timing for initiating any new studies
and the completion of such studies within our stated goals, and increased
manufacturing activity at Avid Bioservices, Inc. due to the signing of new
contracts and the profitability of such contracts. It is important to note
that
the company’s actual results could differ materially from those in any such
forward-looking statements. Factors that could cause actual results to differ
materially include, but are not limited to, uncertainties associated with
completing and the outcomes of preclinical and clinical trials for our
technologies; slower than expected rates of patient recruitment, unforeseen
safety issues resulting from the administration of antibody products in
patients, the significant costs to develop our products as all of our products
are currently in development, preclinical studies or clinical trials and no
revenue has been generated from commercial product sales; obtaining additional
financing to support our operations and the development of our products;
obtaining regulatory approval for our technologies; complying with governmental
regulations applicable to our business; consummating collaborative arrangements
with corporate partners for product development; and achieving milestones under
collaborative arrangements with corporate partners. Our business could be
affected by all of the foregoing and a number of other factors, including the
risk factors listed from time to time in the Company’s SEC reports including,
but not limited to, the annual report on Form 10-K for the year ended April
30,
2005. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not
undertake, to update or revise any forward-looking statements in this press
release.
--tables
to follow--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
THREE
MONTHS ENDED
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NINE
MONTHS ENDED
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||||||||||||
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January
31,
2006
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January
31,
2005
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January
31,
2006
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January
31,
2005
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||||||||||
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Unaudited
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Unaudited
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Unaudited
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Unaudited
|
||||||||||
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REVENUES:
|
|||||||||||||
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Contract
manufacturing revenue
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$
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1,505,000
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$
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1,334,000
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$
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2,227,000
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$
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3,983,000
|
|||||
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License
revenue
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23,000
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19,000
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65,000
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57,000
|
|||||||||
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Total
revenues
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1,528,000
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1,353,000
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2,292,000
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4,040,000
|
|||||||||
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COSTS
AND EXPENSES:
|
|||||||||||||
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Cost
of contract manufacturing
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1,088,000
|
1,273,000
|
1,820,000
|
3,265,000
|
|||||||||
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Research
and development
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3,294,000
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2,548,000
|
9,330,000
|
8,122,000
|
|||||||||
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Selling,
general and administrative
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1,628,000
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1,338,000
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4,715,000
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3,642,000
|
|||||||||
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Total
costs and expenses
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6,010,000
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5,159,000
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15,865,000
|
15,029,000
|
|||||||||
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LOSS
FROM OPERATIONS
|
(4,482,000
|
)
|
(3,806,000
|
)
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(13,573,000
|
)
|
(10,989,000
|
)
|
|||||
|
OTHER
INCOME (EXPENSE):
|
|||||||||||||
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Interest
and other income
|
1,381,000
|
65,000
|
1,585,000
|
197,000
|
|||||||||
|
Interest
and other expense
|
(12,000
|
)
|
(3,000
|
)
|
(35,000
|
)
|
(3,000
|
)
|
|||||
|
NET
LOSS
|
$
|
(3,113,000
|
)
|
$
|
(3,744,000
|
)
|
$
|
(12,023,000
|
)
|
$
|
(10,795,000
|
)
|
|
|
WEIGHTED
AVERAGE
SHARES
OUTSTANDING:
|
|||||||||||||
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Basic
and Diluted
|
171,355,523
|
145,175,059
|
165,772,373
|
142,677,820
|
|||||||||
|
BASIC
AND DILUTED LOSS
PER
COMMON SHARE
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.07
|
)
|
$
|
(0.08
|
)
|
|
--more--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
|
Unaudited
|
|||||||
|
ASSETS
|
|||||||
|
CURRENT
ASSETS:
|
|||||||
|
Cash
and cash equivalents
|
$
|
15,664,000
|
$
|
9,816,000
|
|||
|
Trade
and other receivables, net of allowance for doubtful accounts
of
nil (January) and $69,000 (April)
|
681,000
|
486,000
|
|||||
|
Inventories
|
1,060,000
|
627,000
|
|||||
|
Prepaid
expenses and other current assets
|
867,000
|
1,197,000
|
|||||
|
Total
current assets
|
18,272,000
|
12,126,000
|
|||||
|
PROPERTY:
|
|||||||
|
Leasehold
improvements
|
503,000
|
494,000
|
|||||
|
Laboratory
equipment
|
3,365,000
|
3,029,000
|
|||||
|
Furniture,
fixtures and office equipment
|
666,000
|
647,000
|
|||||
|
4,534,000
|
4,170,000
|
||||||
|
Less
accumulated depreciation and amortization
|
(2,710,000
|
)
|
(2,532,000
|
)
|
|||
|
Property,
net
|
1,824,000
|
1,638,000
|
|||||
|
OTHER
ASSETS:
|
|||||||
|
Note
receivable, net of allowance of nil (January) and
$1,512,000
(April)
|
-
|
-
|
|||||
|
Other
|
680,000
|
481,000
|
|||||
|
Total
other assets
|
680,000
|
481,000
|
|||||
|
TOTAL
ASSETS
|
$
|
20,776,000
|
$
|
14,245,000
|
|||
--more--
PEREGRINE
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (continued)
|
JANUARY
31,
2006
|
APRIL
30,
2005
|
||||||
|
Unaudited
|
|||||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
CURRENT
LIABILITIES:
|
|||||||
|
Accounts
payable
|
$
|
1,493,000
|
$
|
1,325,000
|
|||
|
Accrued
clinical trial site fees
|
211,000
|
8,000
|
|||||
|
Accrued
legal and accounting fees
|
174,000
|
549,000
|
|||||
|
Accrued
royalties and license fees
|
158,000
|
149,000
|
|||||
|
Accrued
payroll and related costs
|
617,000
|
806,000
|
|||||
|
Notes
payable, current portion
|
363,000
|
234,000
|
|||||
|
Capital
lease obligation, current portion
|
15,000
|
-
|
|||||
|
Other
current liabilities
|
267,000
|
563,000
|
|||||
|
Deferred
revenue
|
612,000
|
517,000
|
|||||
|
Total
current liabilities
|
3,910,000
|
4,151,000
|
|||||
|
NOTES
PAYABLE, less current portion
|
457,000
|
434,000
|
|||||
|
CAPITAL
LEASE OBLIGATION, less current portion
|
50,000
|
-
|
|||||
|
DEFERRED
LICENSE REVENUE
|
25,000
|
50,000
|
|||||
|
COMMITMENTS
AND CONTINGENCIES
|
|||||||
|
STOCKHOLDERS'
EQUITY:
|
|||||||
|
Preferred
stock-$.001 par value; authorized 5,000,000 shares; non-voting;
nil
shares outstanding
|
-
|
-
|
|||||
|
Common
stock-$.001 par value; authorized 250,000,000 shares;
outstanding
- 174,109,349 (January); 152,983,460 (April)
|
174,000
|
153,000
|
|||||
|
Additional
paid-in capital
|
198,305,000
|
180,011,000
|
|||||
|
Deferred
stock compensation
|
(319,000
|
)
|
(751,000
|
)
|
|||
|
Accumulated
deficit
|
(181,826,000
|
)
|
(169,803,000
|
)
|
|||
|
Total
stockholders' equity
|
16,334,000
|
9,610,000
|
|||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
20,776,000
|
$
|
14,245,000
|
|||
###